Product code FSH
- Device name
- Tray, Surgical, Needle
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884876 | S 4 INSTRUMENT STAND | Carl Zeiss, Inc. | 1988-12-15 |
| K883578 | S 21 INSTRUMENT STAND | Carl Zeiss, Inc. | 1988-09-13 |
| K821921 | STAND, SURG. INSTRUMENT & DRESSING | Emerson-Sack-Warner Corp. | 1982-07-30 |
| K813337 | SKINNY CHIBA NEEDLE & TRAY | American Pharmaseal Div. Ahsc | 1982-01-28 |
| K813338 | BIOPSY NEEDLES & TRAYS | American Pharmaseal Div. Ahsc | 1982-01-28 |
| K813335 | PERCUTANEOUS TRANSHEPATIC CHOLANG. TRAY | American Pharmaseal Div. Ahsc | 1982-01-08 |
| K780759 | MODEL 902 STAND | Applied Medical Research | 1978-05-19 |
| K772188 | FSH RIA KIT (125I) | Diagnostic Products Corp. | 1977-12-22 |
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| 10603295559696 | INHANCE INTACT | DEPUY (IRELAND) | 2025-06-13 |
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